The present invention relates generally to methods and compositions for providing nutritional requirements to a patient. More specifically, the present invention relates to methods for reducing the risk of hypotension in patient at risk of same.
A number of disease states may place a patient at risk of hypotension. One such disease state is sepsis.
Sepsis has been described as the systemic response to infection. It is an increasingly common cause of morbidity and mortality and has been reported to be the most common cause of death in noncoronary intensive care units. See, Definition for Sepsis and Organ Failure, Critical Care Medicine, Vol. 20, No. 6, p. 864 et. seq. (1992) .
Systemic inflammatory response syndrome describes wide spread inflammation that occurs in patients with such diverse disorders as infection, pancreatitis, ischemia, multitrauma, hemorrhage shock, or immunologically mediated organ injury. Sepsis is a subcategory of the dysfunction. See, Definition for Sepsis and Organ Failure, Critical Care Medicine, Vol. 20, No. 6, pp. 724-725.
When systemic inflammatory response syndrome is due to infection, the terms sepsis and systemic inflammatory response syndrome are synonymous. A frequent complication of systemic inflammatory response syndrome is the development of organ system dysfunction. These include conditions such as: acute lung injury; shock; renal failure; and multiple organ dysfunction syndrome. Supra.
Severe sepsis, which can lead to septic shock, is sepsis associated with organ dysfunction, hypoperfusion, or hypotension. Sepsis-induced hypotension is defined by the presence of a systolic blood pressure of &lt;90 mmHg or its reduction by .gtoreq.40 mmHg from the baseline, in the absence of other causes for hypotension (e.g., cardiogenic shock). Septic shock is defined as sepsis with hypotension along with the presence of perfusion abnormalities. Supra.
Large scale multicenter, sepsis studies, have indicated that there is a continuum of severity that has both infectious and inflammatory components. The condition begins with infection that can lead to sepsis with organ dysfunction and septic shock. Supra, citing: Bone R. C., Risher C. J. Jr., Clemmer T. P., et al: A Controlled Clinical Trial of High-Dose Methylprednisolone in the Treatment of Severe Sepsis and Septic Shock, N Engl J Med 1987; 317:653-658; The Veterans Administration Systemic Sepsis Cooperative Study Group, Effect of High-Dose Glucocorticoid Therapy on Mortality in Patients with Clinical Signs of Systemic Sepsis, N Engl J Med 1987; 317:659-665; Ziegler E. J., Fisher C. J. Jr, Sprung C. L., et al: Treatment of Gram-Negative Bacteremia and Septic Shock With HA-1A Human Monoclonal Antibody Against Endotoxin, N Engl J Med 1991; 324:429-436; and Greenman R. L., Schein R. M. H., Martin M. A., et al: A Controlled Clinical Trial of E5 Murine Monoclonal 1 gM Antibody to Endotoxin in the Treatment of Gram-Negative Sepsis, JAMA 1991; 266:1097-1102.
Septic shock is associated with an increased mortality rate. supra, citing: Bone R. C., Fisher C. J. Jr, Clemmer T. P., et, al: Sepsis Syndrome: A Valid Clinical Entity, Crit Care Med 1989; 17:389-393; Kreger B. E., Craven D. E., McCabe W. R.: Gram-Negative Bacteremia IV. Re-Evaluation of clinical Features and Treatment in 612 Patients, Am J Med 1980; 68:344-350; and Weil M. H., Shubin H., Biddle M.: Shock Caused by Gram-Negative Microorganisms, Ann Intern Med 1980; 60:384-400. Despite the use of innovative therapies, the morbidity and mortality rates in severe sepsis remain high.
Unfortunately, the risk of hypotension in patients suffering sepsis, and certain other disease states, may actually be increased due to compositions that are administered to the patients to meet the patient's nutritional requirements.